TSRH Spinal Screws

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K932029 ↗

FDA Product Code

MNH

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Z-Plate Anterior Fixation System

  Class II

  FDA 510(k) K922543 Active Cleared 19 May 1993

• Titanium Alloy Songer Cable System

  Class II

  FDA 510(k) K920201 Active Cleared 8 Apr 1992

• Titanium Songer Cable System

  Class II

  FDA 510(k) K925812 Active Cleared 24 Mar 1993

• Sentry Posterior Spinal System

  Class II

  FDA 510(k) K930710 Active Cleared 1 Oct 1993

• Resorabplug

  Class II

  FDA 510(k) K920118 Active Cleared 8 Feb 1993

• Reconstruction Plate System

  Class II

  FDA 510(k) K924085 Active Cleared 17 Dec 1992

See all devices from Sofamor Danek Mfg., Inc. →

• What is the TSRH Spinal Screws system used for?

  The TSRH Spinal Screws are designed for internal spinal fixation to stabilize the thoracolumbosacral spine. They are part of a modular system intended to address spinal deformities, instability, or degenerative conditions by providing rigid attachment to vertebral bodies. This allows surgeons to create tailored constructs for individual patient needs during surgical procedures.

• Are these screws single-use or reusable?

  The TSRH Spinal Screws are reusable within their intended surgical context. They are manufactured from titanium and must be handled and stored according to sterile surgical instrument protocols, as they are used in invasive procedures requiring aseptic conditions. Reusability is limited to their original surgical application and does not extend to reuse in MRI environments.

• What materials are the screws made from, and why does it matter?

  The TSRH Spinal Screws are manufactured from titanium, a material chosen for its strength, biocompatibility, and resistance to corrosion. This ensures durability during spinal fixation procedures while minimizing the risk of adverse reactions in the body. Titanium’s properties also support long-term stability in the spine, which is critical for treating deformities or degenerative conditions.

• How should these screws be stored and handled?

  Storage and handling of the TSRH Spinal Screws must comply with sterile surgical instrument protocols due to their use in invasive procedures. They should be kept in a clean, dry environment to prevent contamination and maintained in a way that preserves their sterility until use. Proper storage ensures they remain safe and effective for their intended surgical applications.

• Can these screws be used in MRI environments?

  No, the TSRH Spinal Screws are not intended for use in MRI environments. This limitation is due to the potential for interference with MRI imaging or safety risks associated with metallic implants in magnetic fields. Always verify compatibility with imaging modalities before use.